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EC number: 240-474-8 | CAS number: 16423-68-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviwed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Testing of 24 Food, Drug, Cosmetic, and Fabric Dyes in the In Vitro and the In Vivo/ In Vitro Rat Hepatocyte Primary Culture/ DNA Repair Assays
- Author:
- Douglas Kornbrust and Thomas Barfknecht
- Year:
- 1 985
- Bibliographic source:
- Environmental Mutagenesis 7:101-120 (1985)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: in vivo rat hepatocyte primary culture/DNA repair (HPC/DR) assay
- Principles of method if other than guideline:
- The test chemical was tested for the in vivo rat hepatocyte primary culture/DNA repair (HPC/DR) assay.
- GLP compliance:
- not specified
- Type of assay:
- other: In Vivo/ In Vitro Rat Hepatocyte Primary Culture/ DNA Repair Assays
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Erythrosine
- Molecular formula (if other than submission substance): C20-H6-I4-Na2-O5
- Molecular weight (if other than submission substance): 879.86
- InChl Key (if other than submission substance): RAGZEDHHTPQLAI-UHFFFAOYSA-L
-Substance type- Organic
- Physical state: Solid (powder)
-Purity: 93 % dye
- Impurities (identity and concentrations): 7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: No data available
- Weight at study initiation: 200-300 g
- Assigned to test groups randomly: [no/yes, under following basis: ] No data available
- Fasting period before study: No data available
- Housing: The animals were housed in humidity- and temperature-controlled rooms.
- Diet (e.g. ad libitum): Diet (ad libitum)
- Water (e.g. ad libitum): Water (ad libitum)
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled
- Humidity (%):Controlled
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycles
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: aqueous solutions or corn oil suspensions (for the non-water-soluble dyes)
- Duration of treatment / exposure:
- 2 hour and 15 hour time point
- Frequency of treatment:
- Onces daily
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- six to eight rats
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- o-aminoazotoluene
Examinations
- Tissues and cell types examined:
- Rat hepatocytes
- Details of tissue and slide preparation:
- OTHER: Six to eight rats were perfused on a given day (ie, experiment), including one control (ie, usually corn oil-treated) from which hepatocytes were obtained for in vitro assays. One or more known positive chemicals (usually SY3) were tested .DNA repair was quantified by the autoradiographic determination of incorporated [3H]-thymidine, similar to the method of Williams [1977] and Bermudez et al [1979], as detailed in Kornbrust and Barfknecht [1984a,b]. Net nuclear grains (NNG) were determined by counting the number of grains in each nuclei and subtracting the average number of grains present in three equal-size adjacent cytoplasmic areas. A strict procedure for random selection of cells was used [Mirsalis and Butterworth,1980]. The average NNG for 60 cells (±SD) as well as the percentage of cells with 25 NNG was determined for the test chemical. single dose was given that was equal to approximately 50% of the single dose LD50 (derived from reference toxicity data) or 500 mg/k body weight, whichever was smaller.
- Evaluation criteria:
- Average net nuclear grain counts of 5 or greater were assumed to constitute a positive response, since these differed from the control net nuclear counts by greater than 2 SD. Net nuclear grain counts below zero were considered negative responses.
For those dyes that produced responses between zero and 5 average net nuclear grains, it was generally not possible to demonstrate a statistically significant difference from the control value within a given experiment. Therefore, these responses were judged to be equivocal, unless, in addition to an average net nuclear grain count between zero and 5, at least 25% of the cells examined contained ≥ 5 net nuclear grains, in which case the response was considered weakly positive.
Concentrations of the dyes that produced approximately 90% or greater detachment of the hepatocytes from the coverslips (as assessed visually by comparing to control slides) were assumed to be toxic and were not counted. - Statistics:
- Average net nuclear grains was reported as Mean ± standard deviation
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non mutagenic
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range:
- Solubility:
- Clinical signs of toxicity in test animals:
- Evidence of cytotoxicity in tissue analysed:
- Rationale for exposure:
- Harvest times:
- High dose with and without activation:
- Other:
RESULTS OF DEFINITIVE STUDY : The test chemical was negative i.e gave no induction of DNA repair when tested at 200 mg/plate in Wistar rats
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay):
- Induction of micronuclei (for Micronucleus assay):
- Ratio of PCE/NCE (for Micronucleus assay):
- Appropriateness of dose levels and route:
- Statistical evaluation:
Any other information on results incl. tables
Responses Produced by Various Dyes in the In Vivo/In Vitro HPC/DR Assay
Dye |
Dose |
Time PTPa (hr) |
Avg. NNGb |
Percent cells<5 NNG |
Res- ponse |
Acid red 51 |
200 |
2 15 |
-1.0 (± 3.3) -1.1 (± 3.1) |
5 5 |
N |
aTime that dye was administered prior to start of liver perfusion and isolation of hepatocytes. bAverage net nuclear grains (as defined in the Methods section); mean + standard deviation from 60 cells. CPercent of cells with > S net nuclear grains. dP. positive; WP, weak positive; E, equivocal; N, negative (as per the criteria defined in the Methods section). |
Applicant's summary and conclusion
- Conclusions:
- The test chemical was negative i.e gave no induction of DNA repair when tested at 200 mg/plate in Wistar rats.
- Executive summary:
In vivo HPC/DR genetic toxicity in vivo assay was performed for the test chemical by study on hepatocytes isolated from rat. Six to eight rats were perfused on a given day (ie, experiment), including one control (ie, usually corn oil-treated) from which hepatocytes were obtained for in vivo assays. One or more known positive chemicals (usually SY3) were tested .DNA repair was quantified by the autoradiographic determination of incorporated [3H]-thymidine, similar to the method of Williams [1977] and Bermudez et al [1979], as detailed in Kornbrust and Barfknecht [1984a,b]. Net nuclear grains (NNG) were determined by counting the number of grains in each nuclei and subtracting the average number of grains present in three equal-size adjacent cytoplasmic areas. A strict procedure for random selection of cells was used [Mirsalis and Butterworth,1980]. The average NNG for 60 cells (±SD) as well as the percentage of cells with 25 NNG was determined for the test chemical. single dose was given that was equal to approximately. Average net nuclear grain counts of 5 or greater were assumed to constitute a positive response, since these differed from the control net nuclear counts by greater than 2 SD. The NNG count for the test chemical was less than 5 and the test chemical was negative i.e gave no induction of DNA repair when tested at 200 mg/plate in Wistar rats.
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